Pharma GMP News of the Week: 17-April-2022
Period: April 10, 2022 to April 16, 2022
FDA published Guidance on “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promotional Labeling and Advertising Materials for Human Prescription Drugs”
Date of release: April 11, 2022
The objective of the guidance is to provide requirements of submission of promotional materials for human prescription drugs to the FDA, produced by made by Applicant, Manufacturers, Distributors, Packers, or Entity acting on behalf of the applicant. The guideline also explains aspects e-Submission of promotional materials in eCTD.
The guideline covers:
Advertising and promotional labeling materials, regardless of the manner, format, or medium of presentation. Examples of promotional materials are television ads, booklets, brochures, internet websites, detailing pieces, exhibits, print ads, radio ads, or sound recordings.
Press release from MHRA: “The MHRA are seeking views to strengthen conflicts of interest policy for independent advisors”
Dare of news: April 12, 2022
MHRA has invited UK public and stakeholders to have their view on how the MHRA manages the conflicts of interest for experts those are independent and how involvement of patients in expert committee meetings to ensure transparency and consistency.
MHRA is open for consultation on a new Code of Practice for the Expert Advisory Committees
Date of news: April 12, 2022
MHRA is consulting on a proposals sets to strengthen and improve the Code of Practice for experts.
Where these expert are involved in giving advice that can be used for decisions about the regulation of medical devices and medicines. The objective of this guidance is to ensure that experts giving the advice and opinion as an independent entity and impartial, and process is robust and clear enough to to manage conflicts of interest.
This consultation closes at 11:45pm on May 24, 2022.
EMA and the EUnetHTA 21 joint work plan published “The European Medicines Agency and the European Network for Health Technology Assessment have published a joint work plan until 2023“
Date of news: April 12, 2022
There will be a close collaboration between EMA and Health Technology Assessment (HTA) bodies to bring synergy with the aims to facilitate patients’ access to medicines in the European Union.
U.S. FDA published Manual of Policies and procedures “Classifying Approved New Drug Products and Drug-device Combination Products as Complex Products for Generic Drug Development Purposes”
Date of release: April 13, 2022
The document provides details regarding examples and definitions of drug-device combination products, complex drugs The document also outlined responsibilities and process for the Office of Generic Drugs’ Complex Drug Working Group.
FDA published draft guideline on “Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability”
Date of issue: April 13, 2022
The objective of this guideline is to recommend to sponsors who are in the process of developing medicinal formulations with the approach for evolving a Race and Ethnicity Diversity Plan to select representative Nos. of members from different populations in the US.
This approach helps to ensure that the data gathered during the development work reflect the racial and ethnic diversity and helps to identify effects on efficacy or safety outcomes associated with, or occur commonly within these populations.
FDA published draft Guidance on “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use”
Date of release: April 14, 2022
The objective of this guidance is to identify the information that US FDA commonly asks while evaluating pH adjusters waiver request for generic drug products intended for ophthalmic, parenteral, or otic use. The guidance is applicable for the applicants of ANDA.
News from MHRA: “Sunset clause: request for public health exemption”
On April 14, 2022, the information was updated to provide additional details regarding notification date for changes
Bioavailability Studies Submitted in NDAs or INDs – General Considerations
Date of release: April 15, 2022
The objective of this guideline is to recommend applicants and sponsors for submitting (BA) bioavailability information for INDs, NDAs, and NDA supplements.
The requirement specified in this guidance is for dosage forms applicable for oral route of administration. It includes capsules, tablets, suspensions, solutions, IR, MR, ER, DR drug products.
The guidance also covers details regarding non-orally administered formulations that are appropriate to rely on systemic introduction to determine the BA (e.g., transdermal delivery systems, nasal drug products etc.).
The guideline is not applicable for ANDAs and ANDA supplements.